Int Immunopharmacol . An investigation into the beneficial effects of high-dose interferon beta 1-a, compared to low-dose interferon beta 1-a in severe COVID-19: The COVIFERON II randomized controlled trial

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Int Immunopharmacol


. 2021 Jun 29;99:107916.
doi: 10.1016/j.intimp.2021.107916. Online ahead of print.
An investigation into the beneficial effects of high-dose interferon beta 1-a, compared to low-dose interferon beta 1-a in severe COVID-19: The COVIFERON II randomized controlled trial


Ilad Alavi Darazam ¹ , Firouze Hatami ² , Mohammad Mahdi Rabiei ² , Mohamad Amin Pourhoseingholi ³ , Minoosh Shabani ² , Shervin Shokouhi ² , Masoud Mardani ² , Omid Moradi ⁴ , Farid Javandoust Gharehbagh ⁵ , Nasrinsadat Mirtalaee ² , Halimeh Negahban ² , Mahdi Amirdosara ⁶ , Masoud Zangi ⁷ , Mohammadreza Hajiesmaeili ⁶ , Muhanna Kazempour ⁸ , Navid Shafigh ⁶



Affiliations

• PMID: 34224994
• DOI: 10.1016/j.intimp.2021.107916

Abstract

Introduction: Coronavirus disease 2019 (COVID-19) has been a serious obstacle in front of public health. Interferon-beta 1a (IFN-β 1a) has been used to treat patients with COVID-19. We aimed to compare the effectiveness of high-dose IFN-β 1a compared to low dose IFN-β 1a in severe COVID-19 cases.
Methods: In this randomized, controlled, and clinical trial, eligible patients with confirmed SARS-CoV-2 infections were randomly assigned to receive one of the two following therapeutic regimens: The intervention group was treated with high-dose IFN-β 1a (Recigen) (Subcutaneous injections of 88 μg (24 million IU) on days 1, 3, 6) + lopinavir /ritonavir (Kaletra) (400 mg/100 mg twice a day for 10 days, orally) and the control group was treated with low-dose IFN-β 1a (Recigen) (Subcutaneous injections of 44 μg (12 million IU) on days 1, 3, 6) + lopinavir /ritonavir (Kaletra) (400 mg/100 mg twice a day for 10 days, orally).
Result: A total of 168 COVID- 19 confirmed patients underwent randomization; 83 were assigned to the intervention group and 85 were assigned to the control group. Median Time To Clinical Improvement (TTIC) for cases treated with low-dose IFN-β1a was shorter than that for cases treated with high-dose IFN-β1a (6 vs 10 days; P = 0.018). The mortality rates in intervention and control group were 41% and 36.5%, respectively.
Conclusion: The use of high-dose IFN-β 1a did not improve TTCI in hospitalized patients with moderate to severe COVID-19. Also, it did not have any significant effect on mortality reduction compared with treating with low-dose IFN-β 1a.
Trial registration: This trial has been registered as ClinicalTrials.gov, NCT04521400.

Keywords: COVID-19; Interferon-β 1a; Lopinavir/ritonavir; Randomized controlled trial; SARS-COV-2.